Project Summary The Clinical Cell and Vaccine Production Facility is a Shared Resource of the Abramson Cancer Center (ACC) that is jointly managed with the Department of Pathology and Laboratory Medicine at the University of Pennsylvania. Bruce Levine, PhD, Barbara and Edward Netter Professor in Cancer Gene Therapy, has overseen the Facility since its inception, initially as a pilot Facility and then a developing Facility in 1999. The mission of the Facility is to facilitate translation of bench-to-bedside research in novel allogeneic and autologous cell-based vaccines and experimental gene therapies. The Facility performs cell and biologic processing and expansion on a range of different cell types, including peripheral blood and umbilical cord blood derived CD4+ and CD8+ T lymphocytes, monocyte derived dendritic cells, and bone marrow derived mesenchymal stem cells in support of first-in-human and early Phase I and II cell and gene therapy clinical trials, with an emphasis on cancer. The Facility provides a range of services to ACC investigators to support preclinical process development and validation experiments for successful Good Manufacturing Practices (GMP) clinical translation, clinical trial manufacturing, and specified testing for cell and gene therapy products for human administration. Notable accomplishments facilitated by the Facility have been first-in-human trials, including the first use of a lentiviral vector, the first infusions of zinc finger nuclease genome-modified cells, and the first use of lentivirally-modified cells to treat cancer. In 2005, with a considerable investment of non-Core Grant Funds from the University of Pennsylvania Health System, the Abramson Cancer Center and the Department of Pathology and Laboratory Medicine, this facility expanded into a newly renovated 10-room GMP suite within the Hospital of the University of Pennsylvania (HUP). In 2013, demonstrating continued and significantly increasing investigator usage of the Facility the Facility opened a second 10-room GMP suite in HUP (with additional investment of non-Core funds), effectively doubling capacity. These facilities are the only spaces on campus that can perform cell and tissue processing in compliance with FDA regulations 21 CFR Parts 210 and 211. Since 1999, Dr. Levine and the Facility have supported >30 FDA Investigational New Drug Applications at Penn and external institutions and produced over 2000 cellular vaccines that have been safely administered to more than 700 patients. The Facility currently supports manufacturing for 18 investigational new drug applications (INDs). The quality and the quantity of projects and clinical products generated in the Facility are recognized among collaborating institutions and pharmaceutical partners. In the reporting period (10/01/13-09/30/14), 19 investigators used the Facility, of which ACC member usage represents 58%. CCSG support represents 2% of the proposed Facility budget with the remaining funding coming from charge backs and other grants/contracts.